How does antibiotic imitation seem to look like

The reporter was informed that the China National Institute for Food and Drug Control (hereinafter referred to as the "China Inspection and Quarantine") has been organizing the nationwide drug testing agency to carry out evaluation testing of listed drugs in recent years. From 2008 to 2012, 84 antibiotic varieties and preparations were involved, mainly including 23 cephalosporins, 13 penicillins, 12 meteorites, 11 macrolides, etc.

“The fundamental purpose of this work is to improve the quality of products.” Hu Changqin, chief expert of chemical medicine, director of the antibiotics office and director of the Microbiology Detection Laboratory of the Central Inspection and Quarantine Institute, introduced that the drug evaluation test is based on the analysis of the supervision and inspection of the drug market and finds the main quality problems. Investigate the cause of the problem, and improve the standards of pharmaceuticals to encourage enterprises to improve the process and improve the quality of products so as to ensure the quality of the listed products.

At the same time, exploratory testing is still conducted exploratory studies, including the rationality of impurity control, the evaluation of the release and dissolution characteristics of oral preparations, the influence of packaging materials and packaging on the quality of medicines, and the rationality evaluation of formulation prescriptions.

"At present, China's concept of controlling the spectrum of antibiotic impurity has been generally accepted, and the evaluation of consistency in the quality of generic drugs has begun, but the quality control concept based on QbD (Quality Originated from Design) is still in its embryonic state." Recently, Hu Changqin In the antibiotic clinical R & D production and marketing national academic conference said.

Trapped in passive satisfaction standards

It is understood that the conventional indicators in the quality analysis of antibiotics mainly include the dissolution rate, active ingredient content, impurities, the difference in loading capacity, and the uniformity of the content. Hu Changqin said that according to the Pharmacopoeia standard test, with the exception of individual varieties in individual years, the passing rate of antibiotic products in China was above 95%, and basically no issues such as low-limit feeding were found. The higher rate of disqualifications of individual varieties is basically related to the compatibility of drugs and imperfections in drug quality standards.

At present, the common quality problem is that some companies passively meet drug standards and have relatively weak cognition of drug impurities, ignoring the pursuit of optimal production processes and research on pharmaceutical preparations. In this regard, Professor Jin Shaohong from the China Institute of Inspection and Prosecution pointed out that due to the limitations of drug quality standards, the cause of adverse drug events in clinical practice cannot be concluded simply because the test results do not meet the quality standards of the drug, and comprehensive comprehensive evaluation must be conducted. "The key points of quality control of antibiotics are to ensure the safe use of antibiotics and to ensure the effective clinical use of antibiotics. Enterprises must pay attention to the crystal shape and particle size distribution of drugs, the compatibility of drugs and packaging materials, and the stability of drugs."

"What is worthy of recognition is that the production hardware conditions of most domestic companies have been greatly improved, and the quality of some traditional antibiotics has significantly improved," said Hu Changqin.

Quality Control in QbD

With the development of the quality consistency assessment of generic drugs, the evaluation of the consistency of antibiotic quality is also in progress. Jin Shaohong proposed that, first of all, it is necessary to make full use of the information of clinical institutions, that is, to provide accurate clinical medicine and pharmacy information by retrospective analysis of clinical risk assessment of the same antibiotic at home and abroad, and to summarize, summarize, and propose clinically inconsistent specifics. Whether the performance is in terms of efficacy, ADR, bioequivalence, or pharmacology; secondly, scientific analysis of varieties, definitive re-evaluation of varieties is real imitation, or “looks like”, the real imitation must be “four simultaneous”—the same API, the same dosage form, The same specifications and the same route of administration, but also pay attention to distinguish imitation and "homemade", validation of the prescription of compound preparations and large-capacity drug-containing injection of the rationality.

Many experts believe that emphasizing the "consistency" of generic drugs means that they must conduct comprehensive research on pharmaceuticals during the development process, and conduct comprehensive control of quality during the production process.

For the improvement of the product quality of antibiotic production enterprises in China, Hu Changqin proposed: The first is the impurity spectrum control. The focus of antibiotic impurity research is the confirmation of impurity structure, the assessment of impurity toxicity, the process impurities and degradation impurities in the formulation, and the correlation between the impurity limit of the formulation and the raw material process. "The control of related substances in drugs will become the main means of building technical barriers in the coming period."

Second, production process control will be the core technology for future drug production. Process analysis (PAT) can identify and confirm raw materials and preparations and solve problems in the production process. “GMP was once an important technical barrier that restricted the internationalization of pharmaceutical companies in China. The future of PAT technology may become another technical barrier for pharmaceutical companies in international competition.”

In addition, quality control systems based on QbD, including GMP management and PAT control, require not only a full range of research on the products during the drug development process, but also the continuation of their production processes after the approval of drugs is listed. Control and improvement to ensure continuous understanding and improvement of the product.